Soft tissue repair device and associated methods

ABSTRACT

A soft tissue repair device. The device includes an inserter having a distal portion, a first anchor carried externally onto the distal portion, a second anchor carried externally onto the distal portion, and a flexible strand coupling the first and second anchors and forming an adjustable knotless loop.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/891,049 filed on Feb. 7, 2018, now U.S. Pat. No. 10,932,770, which isa continuation of U.S patent application Ser. No. 14/876,167 filed onOct. 6, 2015, now issued as U.S. Pat. No. 10,251,637, which is acontinuation of U.S. patent application Ser. No. 13/656,821 filed onOct. 22, 2012, now issued as U.S. Pat. No. 9,173,651, which is adivisional of U.S. patent application Ser. No. 13/045,691 filed on Mar.11, 2011, now issued as U.S. Pat. No. 8,292,921, which is a divisionalof U.S. patent application Ser. No. 12/014,399 filed on Jan. 15, 2008,now issued as U.S. Pat. No. 7,909,851, claims the benefit of U.S.Provisional Application No. 60/885,062, filed on Jan. 16, 2007, and ofU.S. Provisional Application No. 60/885,057, filed on Jan. 16, 2007. Thedisclosures of the above applications are incorporated herein byreference.

INTRODUCTION

Tears caused by trauma or disease in soft tissue, such as cartilage,ligament, or muscle, can be repaired by suturing. Various repair deviceshave been developed for facilitating suturing and are effective fortheir intended purposes. Nevertheless, tissue repair devices forfacilitating suturing are still desirable.

SUMMARY

The present teachings provide a soft tissue repair device. The devicecan include an inserter having a distal portion, first and secondanchors carried externally onto the distal portion, and a flexiblestrand coupling the first and second anchors and forming an adjustableknotless loop.

In one aspect, each of the first and second anchors is a flexible sleevehaving first and second ends and an internal passage between the firstand second ends. In another aspect, each of the first and second anchorsis substantially rigid having first and second ends and an internalpassage between the first and second ends.

The present teachings also provide a method for repairing a tear in ameniscus during arthroscopic knee procedure. The method includescoupling first and second anchors with a flexible strand, forming anadjustable knotless loop with the flexible strand, and loading the firstand second anchors coupled with the adjustable knotless loop on anexternal surface of an inserter. The method further includes insertingthe inserter through the tear to an outer surface of the meniscus,sequentially deploying the first and second anchors from the inserter onan outer surface of the meniscus, self-locking the adjustable loop, andreducing the tear.

Further areas of applicability of the present invention will becomeapparent from the description provided hereinafter. It should beunderstood that the description and specific examples are intended forpurposes of illustration only and are not intended to limit the scope ofthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more fully understood from thedetailed description and the accompanying drawings, wherein:

FIG. 1 is a perspective view of a tissue repair device according to thepresent teachings shown in a first configuration;

FIG. 1A is a perspective view of a flexible anchor according to thepresent teachings;

FIG. 2 is a perspective view of the device of FIG. 1 , shown in a secondconfiguration;

FIG. 3 is a perspective view of the device of FIG. 1 , shown in a thirdconfiguration;

FIG. 4 is a perspective view of the device of FIG. 1 , shown in a fourthconfiguration;

FIG. 5 is a perspective view of the device of FIG. 1 , shown in a fifthconfiguration;

FIG. 6 is a perspective view of a tissue repair device according to thepresent teachings;

FIG. 7 is an enlarged side view of the device of FIG. 6 , shown with adepth limiting device in a first position;

FIG. 8 is an enlarged side view of the device of FIG. 6 , shown with adepth limiting device in a second position:

FIG. 9 is an environmental view showing one anchor deployed outside softtissue according to the present teachings; and

FIGS. 10 and 10A are environmental view showing two anchors deployedoutside soft tissue according to the present teachings;

FIG. 11 is a perspective view of a tissue repair device according to thepresent teachings shown in a first configuration;

FIG. 12 is a perspective view of the device of FIG. 11 , shown in asecond configuration;

FIG. 13 is a perspective view of the device of FIG. 11 , shown in athird configuration;

FIG. 13A is a perspective view of the device of FIG. 11 , shown in afourth configuration;

FIG. 14 is a perspective view of a tissue repair device, according tothe present teachings, shown in a first configuration;

FIG.14A is a perspective view of the device of FIG. 14 , shown in asecond configuration;

FIG. 15 is a perspective view of the device of FIG. 14 , shown in athird configuration;

FIG. 16 is a perspective view of a tissue repair device according to thepresent teachings;

FIG. 16A is an enlarged side view of the device of FIG. 16 ;

FIG. 17 is a perspective view of a tissue repair device according to thepresent teachings;

FIG. 17A is an enlarged side view of the device of FIG. 1

FIG. 18 is an environmental view showing one anchor deployed outsidesoft tissue according to the present teachings;

FIGS. 19 and 19A are environmental views showing two anchors deployedoutside soft tissue according to the present teachings:

FIGS. 20, 21, 22, and 23 are sequential views illustrating an exemplarymethod of coupling first and second flexible anchors with a flexiblestrand, and FIG. 22A shows a detail of FIG. 22 ;

FIG. 24 is a perspective view of a flexible anchor coupled with aflexible strand;

FIG. 25A is a bottom view of an anchor according to the presentteachings;

FIG. 25B is a top view of the anchor of FIG. 25A;

FIG. 26 is a view illustrating coupling first and second anchors with aflexible strand according to the present teachings; and

FIG. 27 is a perspective view showing first and second anchors loadedonto an inserter according to the present teachings.

DESCRIPTION OF VARIOUS ASPECTS

The following description is merely exemplary in nature and is in no wayintended to limit the invention, its application, or uses. For example,although the present teachings are illustrated in an application formeniscus repair in knee surgery, the present teachings can also be usedfor repairing any fibrous tissue, such as muscle, ligament or tendon nan arthroscopic or other open procedure, including rotator cuffreconstruction, acromioclavicular (AC) reconstruction, anterior cruciateligament reconstruction (ACL) and generally for fastening tendons,grafts, or strands to fibrous tissue and bone.

An exemplary tissue repair device 100 according to the present teachingsis illustrated in FIG. 1 . The device 100 can include an inserter 102, astop member or shaft 106 and a depth limiting device 250, such as aplastic tube that can be cut to desired length. The inserter 102 can beexternally pre-loaded on its outer surface with one or more flexibleanchors 150. Two anchors 150 are illustrated in FIG. 1 and arereferenced hereinafter as first and second anchors 150 a, 150 b, ifdesirable for further clarity. The letters “a” and “b” will also beappended to distinguish corresponding features of the first and secondanchors 150 a, 150 b, if desirable for clarity. The inserter 102 caninclude a distal portion 108 defining an inclined sharp edge 110. Theinserter 102 can define an open longitudinal channel 112. An anchordeploying member 130 can be slidably received in the channel 112 fordeploying the anchors 150 off the inserter 102. The shaft 106 can besolid or hollow, and can operate as a stop member for the anchors 150 a,150 b, which are not loaded in or within the longitudinal channel 112 asin prior art devices, but are instead carried externally and completelyoutside the distal portion 108 of the inserter 102, with no portion ofthe anchors 150 received within the longitudinal channel 112, asdescribed below.

Referring to FIGS. 1, 1A and 2 , each flexible anchor 150 can be anelongated member having first and second ends 152, 154. The first andsecond ends 152, 154 are blunt and substantially perpendicular to thelongitudinal axis of the anchor 150. The flexible anchor 150 can be madeof resorbable or non-resorbable materials, including braided suture,sponges and sponge-like materials in solid form, perforated materials,woven/braided from biocompatible materials or fibers, such as, forexample, polymer, polyester, polyethylene, cotton, silk, or othernatural or synthetic materials, include sponges and sponge-likematerials. The flexible anchor 150 can also be an elongated tubular orsolid member or a two-dimensional member with or without internal bores.The flexible anchor 150 can have any properties that allow the flexibleanchor 150 to change shape. The flexible anchor 150 can be, for example,compliant, flexible, foldable, squashable, squeezable, deformable, limp,flaccid, elastic, low-modulus, soft, spongy, perforated or any otherflexible member which can change shape. In some aspects, the flexibleanchor 150 can be coated with biological or biocompatible coatings, andit can also be soaked in platelets and other biologics, which can beeasily absorbed by the flexible anchor 150 in particular when, forexample, the flexible anchor 150 is made from spongy, absorbentmaterial.

It should be understood by the above description that the flexibleanchor 150 cannot pierce or otherwise penetrate tissue either with thefirst and second ends 152, 154, which are blunt or with any otherportion thereof. The flexible anchor 150 can be loaded solely on theexterior of the distal portion 108 of the inserter 102 in a foldedconfiguration, such that the first and second ends 152, 154 are facingeach other. Accordingly, no portion of the flexible anchor 150 isreceived even partially in or within the inserter 102 or the channel112, in contrast to prior art devices in which one or more anchors aresubstantially received within hollow tubular inserters or hollowneedles. More specifically, an intermediate portion 156 of the flexibleanchor 150 can be pierced through by the sharp edge 110 of the inserter102, such that the first and second ends 152, 154 extend opposing oneanother along the proximal portion 108 of the inserter 102, as shown inFIG. 1 . The flexible anchor 150 can be in the form of an elongateflexible tube defining a bore 158 along its length, as shown in FIG. 1A.The flexible anchor 150 can be formed of suture braided without a core.

Referring to FIGS. 6-8 the device 100 can include an adjustment actuator500 for the depth limiting device 250. The actuator 500 can be, forexample, a rack-and-gear mechanism for moving the inserter 102 relativeto the depth limiting device 250 between the position shown in FIG. 7 ,in which the inserter 102 extends a distance “D” beyond a distal end 252of the depth limiting device 250, and the position of FIG. 8 , in whichthe inserter 102 extends a distance “D′” beyond the distal end 252 ofthe depth limiting device 250. The depth limiting device 250 can be inthe form of a transparent plastic tube.

The inserter 102 can be used with a cannula 200, shown in FIG. 16 . Thecannula 200 can include a handle 202 and a tubular or hollow shaft 204.The shaft 204 of the cannula 200 can have a longitudinal bore 220 havingan inner diameter sized to receive the inserter 102. The shaft 204 ofthe cannula 200 can have a distal end 206 which can be perpendicularrelative to the shaft 204, as shown in FIG. 16 , but can also be slantedrelative to the shaft 204. The distal end 206 has a rounded, blunt orsmooth edge not intended to or capable of piercing or otherwisepenetrating tissue. The cannula shaft 204 can include a cut-away slot208 defining a viewing window 210, as shown in FIG. 17 .

Referring to FIG. 1A, the flexible anchor 150 can be assembled bent in aU-shape form on the inserter 102 with a continuous strand loop 300attached thereon. The strand loop 300 can be formed by a single segmentof flexible strand 301 passing through the bore 158 of the anchor 150,such that the strand loop 300 includes a first external segment orportion 302 outside the bore 158 and between the ends 152, 154, and asecond external segment portion 304 located outside the bore 158 andexiting the bore 158 from exit openings 160, 162 on opposite sides ofthe bent U-shape of the flexible anchor 150. The flexible strand 301 canbe made of braided filaments or fibers of biocompatible material,including natural and synthetic fibers, such as cotton, silk, polymer,polyester, polyethylene, thin wire, suture, and other materials.

The strand loop 300 can be formed by tying the ends of the segment witha knot 306 which can be positioned on either the first external portion302 or the second external portion 304. It will be appreciated that theloop 300 can define first and second secondary loops or sub-loops 310,312. The first sub-loop 310 can include the first external portion 302,and the second sub-loop can include the second external portion 304. Thefirst and second sub-loops 310, 312 can intersect each other, and eachsub-loop 310, 312 can pass through the bent portion of the bore 158corresponding to the intermediate portion 156 of the flexible anchor150.

Referring to FIGS.1-6, the deploying member 130 can include anelastically deformable projection 132, which can be used to push theanchor 150 off the inserter 102. The deploying member 130 can be movedaxially along the channel 112 of the inserter 102 by moving a thumbslider 120 of the handle 104 forward or backward relative to the handle104 of the inserter 102, as shown in FIG. 6 . In the assembled positionbefore deployment of either anchor 150 a, 150 b, the projection 132 ofthe deploying member 130 can sit behind the first anchor 150 a, as shownin FIG. 1 . After the first anchor 150 a is deployed, the deployingmember 130 can be retracted, such that the projection 132 is compressedinward and deformably pulled through the body of second anchor 150 b.When the projection 132 exits the second anchor 150 b, the projection132 springs back to its original shape for pushing the second anchor 150b off the inserter 102, as shown in FIGS. 2 and 3 . The loops 300 a, 300b of the first and second anchors 150 a, 150 b can be connected with aflexible strand 350 that has a free end 352 and includes a slip knot 356thereon. The flexible trand 350 can loop around each of the externalsegments 304 a and 304 b, as shown in FIG. 4 .

An alternative arrangement for coupling the first and second flexibleanchors 150 a, 150 b with a flexible, strand forming an adjustableknotless loop is discussed below in reference to FIGS. 20-24 .

Referring to FIGS. 3-5, 9, and 10 , the soft tissue repair device 100can be used to repair a soft tissue defect 90, such as, example, a tear,or other weakness in fibrous soft tissue 80, such as in meniscal tissue,cartilage, muscle or other fibrous tissue under the skin. After an outerincision is made through the skin to access the soft tissue 80, thecannula 200 can be positioned through the outer incision without cuttingor piercing any tissue and placed adjacent the fibrous soft tissue 80,as shown in FIG. 10 . The cannula 200 can, therefore, operate as anaccess portal for the inserter 102. The inserter 102 can be assembledwith the first and second anchors 150 a, 150 b externally carriedthereon, as shown in FIG. 1 .

Referring to FIGS. 9, 10 and 10A, the inserter 102 can be passed throughthe cannula 200 and into the soft tissue 80 from a first side of thedefect 90 until the distal portion 108 of the inserter 102 can exit asecond side 82 of the fibrous soft tissue 80, such as an outer surfaceor back side of a meniscus of a knee joint or other outer surface of afibrous tissue, for example. The deploying member 130 can be movedforward relative to the inserter 102, thereby delivering the firstanchor 150 a on the second side 82 of the soft tissue 80 at a firstlocation, as shown in FIG. 9 .

It will be appreciated that the manner and structure of thepre-assembled inserter 102 and anchor 150 allows the anchor 150 to passthrough a narrow opening or slit formed in the tissue 80 by the edge 110of the inserter 102 in a first low-profile folded configuration defininga plane “A”, as shown in FIG. 2 , and deposited in that configurationoutside the tissue 80 with its first and second ends 152, 154 beingdelivered substantially simultaneously. Further, it will be understoodthat tightening the first strand loop 300 by pulling on the secondexternal portion 304 can cause the anchor 150 to deform to a secondconfiguration having a substantially flat round-like or knurled shape.Further pulling on the second external portion 304 can rotate the anchor150 from a first orientation defined by plane A and substantiallyperpendicular to the outer surface 82 to a second orientation such thatthe deformed anchor 150 can define a plane “B” substantially parallel toand lying on the outer surface 82 of the soft tissue 80 in asubstantially flat shape, as shown in FIG. 10 .

After the first anchor 150 a is deployed, the deploying member 130 canbe pulled behind the second anchor 150 b. The second anchor 150 b can bepushed off the distal portion 108 of the inserter 102, as shown in FIGS.4 and 5 , and be delivered to the second side 82 of the soft tissue 80at a second location, as shown in FIG. 10 . The inserter 102 can then beremoved. The free end 352 of the strand 350 can be tensioned, therebydeforming the second anchor 150 b to a substantially flat round-like orknurled configuration that lays flat on the second side 82 of the softtissue 80, and compressing the defect 90. Any excess portion of thestrand 350 can be out off.

Referring to FIGS. 11-19 , a similar procedure can be used to repair adefect 90 in soft tissue 80 using non-deformable or substantially rigidanchors 600, which can be referenced as first and second anchors 600 a,600 b, if distinction is desirable for clarity. The anchors 600 can bemade of any biocompatible material, such as, for example, titanium orother non-resorbable material, a resorbable or bioabsorbable polymericor other material, including Lactosorb®, commercially available fromBiomet, Inc, Warsaw, Ind. Referring to FIG. 12 , each anchor 600 can bea tubular member defining a longitudinal bore 602 that extends betweenfirst and second ends 604, 606 of the anchor 600. The longitudinal bore602 can be substantially D-shaped. The ends 604, 606 of the anchor 600can have rounded edges substantially perpendicular to the anchor 600 a,such that the ends 604, 606 are not capable and not intended forpiercing or penetrating tissue. The anchor 600 can further define atransverse bore 610 oriented at an angle to the longitudinal bore 602,such as, for example, 90-degrees or other suitable angle relative to thelongitudinal bore 602.

The first and second anchors 600 a, 600 b can be coupled with a flexiblestrand 680 that passes through the transverse bore 610 a of the firstanchor 600 a. Both ends 682, 684 of strand 680 can be passed through thetransverse bore 610 b of the second anchor 600 b and tied to a slip knot686, leaving one free end 682 for tightening the strand 680, as shown inFIGS. 11-13A.

Alternatively, flexible strand loops 620 a and 620 b can be formedthrough the respective transverse bores 610 a, 610 b of the first andsecond anchors 600 a, 600 b, as shown in FIG. 14 . A flexible strand 680can then be used to connect the two loops 620 a, 620 b, as shown inFIGS. 14A and 15 .

Referring to FIGS. 16-19A, the anchor 600 can be inserted throughfibrous tissue using the inserter 102 with the cannula 200, and can beused for fibrous soft tissue repair as described above. In one exemplaryprocedure, the inserter 102 can be passed through the cannula 200 intothe soft tissue 80 from a first side of the defect 90 until the distalportion 108 of the inserter 102 can exit a second side 82 of the softtissue 80, such as an outer surface or back side of a meniscus of a kneejoint or other outer surface of a fibrous tissue, for example. Thedeploying member 130 can be moved forward thereby delivering the firstanchor 600 a on the second side 82 of the soft tissue 80 at a firstlocation, as shown in FIG. 18 .

The deploying member 130 can then be pulled behind the second anchor 600b, as the projection 132 is compressed inward and passes through thebore 602 b of the second anchor 600 b. After the projection 132 exitsthe second anchor 600 b, the projection springs back to is originalshape behind the second anchor 600 b. The second anchor 600 b can bepushed off the distal portion 108 of the inserter and be delivered tothe second side 82 of the soft tissue 80 at a second location, as shownin FIG. 19 . The inserter 102 can then be removed. The free end 682 ofthe strand 680 can be tensioned, thereby rotating the anchors 600 a, 600b, such that each anchor 600 a, 600 b is positioned with itslongitudinal axis parallel to the surface of the second side 82 of thesoft tissue 80, as shown in FIG. 19A. Tensioning the strand 680 furthercan compress the defect 90. Any excess portion of the strand 380 can becut off.

Alternative non-deformable anchors and loop arrangements are discussedbelow in reference with FIGS. 25A-27 .

Referring to FIGS. 20-24 , another aspect of coupling the flexibleanchors 150 a, 150 b with a flexible strand 900 is illustrated. Theflexible strand 900 can have first and second ends 902, 904 and can bemade of materials similar to those discussed above in reference to theflexible strand 301. The flexible strand 900 can be braided in a tubularor hollow form such that it forms an internal passage 901 between thefirst and second ends 902, 904. A small knot or other retaining device906 can be optionally formed adjacent the first end 902. The flexiblestrand 900 can be passed through a first opening 160 of each of theflexible anchors 150 a, 150 b, guided along the corresponding bore 158and exit through a second opening 162 of each flexible anchor 150 a, 150b, as shown in FIG. 21 . The openings 160, 162 can be positionedintermediately between the first and second ends 152, 154 of eachflexible anchor 150 a, 150 b at a distance of, for example, one-quarterlength from the ends 152, 154 of each flexible anchor 150 a, 150 b.Furthermore, it will be appreciated that the openings 160, 162 can beapertures or voids in the woven fabric of the flexible anchors 150 a,150 b, such that the openings 160, 162 do disrupt or break the weave offlexible anchors 150 a, 150 b, when the flexible anchor 150 a, 150 b aremade of braided or woven material,

After the flexible anchors 150 a, 150 b are mounted on the flexiblestrand 900, the second end 904 of the flexible strand 900 can beinserted into the internal passage 901 of the flexible strand 900 at anaperture 903, guided longitudinally along the passage 901, and led outof the passage 901 of the flexible strand 900 at an aperture 905. Theportion of the strand 900 between apertures 901 and 905 can form anadjustment portion 908 between the optional knot 906 and the opening 160of the second flexible anchor 150 b, such that the flexible strand 900defines a single adjustable knotless loop 910, as shown in FIGS. 22 and22A. The second flexible anchor 150 b can be slidably moved along theflexible strand 900 until the adjustment portion 908 is within the bore158 of the second flexible anchor 150 b and the knot 906 is adjacent theopening 160 of the second flexible anchor 150 b, as shown in FIG. 23 .It will be appreciated, however, that the adjustment portion 908 canremain in the position shown in FIG. 22 . The adjustable knotless loop910 is self-locking and does not require the surgeon to tie a knotduring the surgical procedure for securing the flexible strand 900.Further, once the adjustable knotless loop 910 is self-locked by pullingthe second end 904 of the flexible strand 900 and tensioning theflexible strand 900, friction prevents the adjustable knotless loop 910from being loosened, thereby providing a secure lock. Additional detailsregarding forming the knotless adjustable loop 910, and additionaladjustable knotless loop configurations are disclosed in co-pending andcommonly assigned U.S. Patent application Ser. No. 11/541506, filed onSep. 29, 2006, the disclosure of which is incorporated herein byreference.

The first and second flexible anchors 150 a, 150 b can be loaded on theinserter 102, as shown in FIG. 1 and discussed above, coupled with theflexible strand 900, which forms the closed adjustable knotless loop910. Pulling the second end 904 of the flexible strand 900 can deformthe first and second flexible anchors 150 a, 150 b for anchoring, andshorten the length of the adjustable knotless loop 910 without using aslipknot. The inserter 102 with the flexible anchors 150 a, 150 bpre-loaded thereon can be used for repairing soft tissue 80, such as ameniscus tear 90, in a similar manner as discussed with reference toFIG. 9 , for example. The thumb slider 120 can be moved forward todeploy the first flexible anchor 150 a at an outer surface 82 of thesoft tissue. The thumb slider 120 can then be moved backward, enablingthe deploying member 130 to be retracted to a position for deploying thesecond flexible anchor 150 b at the outer surface 82 of the soft tissueand adjacent the first flexible anchor 150 a. Pulling the second end 904of the flexible strand 900 can tighten the adjustable knotless loop 910,secure the first and second flexible anchors 150 a, 150 b against theouter surface 82 of the soft tissue 80 and reduce the defect 90.Further, the portions of the sleeve between the first and second ends152, 154 of each of the flexible anchors 150 a, 150 b and thecorresponding first and second openings 160, 162, define anchoring legportions that provide additional resistance for securing the flexibleanchors 150 a, 150 b on the outer surface 82 of the soft tissue 80, asthese leg portions are forced against the outer surface 82 foranchoring.

Referring to FIGS. 25A-27 , another non-deformable or substantiallyrigid anchor 1000 is illustrated. Similarly to the anchors 600 a, 600 billustrated in FIG. 11 the anchor 1000 can be made of any biocompatiblematerial, such as, for example, titanium or other non-resorbable orresorbable material, including polymeric materials and Lactosorb®commercially available from Biomet, Inc., Warsaw, Ind., and can besimilarly used to repair a soft tissue defect 90. The anchor 1000 can betubular defining a longitudinal bore 1002 that extends between first andsecond ends 1004, 1006 of the anchor 1000, and can have an open,channel-like cross-section defining an arc of 180 degrees or more. Theends 1004, 1006 of the anchor 1000 can have blunt rounded edgessubstantially perpendicular to the anchor 1000, such that the ends 1004,1006 are not capable and not intended for piercing or penetratingtissue. The anchor 1000 can further define first and second throughbores 1010 oriented substantially perpendicularly to the anchor 1000 andcommunicating with the longitudinal bore 1002. A flexible strand 900 canbe passed through the through bores 1010 coupling the first and secondanchors 1000 a, 1000 b with an adjustable knotless loop 910, as shown inFIG. 26 . The strand 900 can be tightened by pulling on the second end904 of the flexible strand 900 without using a slipknot, as discussedabove.

The first and second anchors 1000 a, 1000 b, coupled with the flexiblestrand 900, can be mounted on a single inserter 102, as described abovein connection with FIG. 11 . Another exemplary inserter 1050 for usewith the first and second anchors 1000 a, 1000 b is shown in FIG. 27 .The inserter 1050 can have a cylindrical body 1052, a pointed distal tip1054, and a stop 1056. The first anchor 1000 a can be mounted externallyonto the body 1052 of the inserter 1050 between the tip 1054 and thestop 1056, such that a portion of the inserter 1052 is received in thelongitudinal bore 1002 of the first anchor 1000 a. The second anchor1000 b can be similarly mounted externally onto the body 1052 of theinserter 1050 behind the first anchor 1000 a and facing in a directionopposite to the first anchor 1000 a and opposite to the stop 1056.

In use, the inserter 1050 can be pushed through the soft tissue 80 andthrough the defect 90 to the outer surface 82 of the soft tissue 80carrying the first anchor 1000 a therethrough. The stop 1056 preventsthe anchor 1000 a from sliding backward when the inserter 1050 isretracted out of the soft tissue 80, leaving the first anchor 1000 a onthe outer surface 82. The second anchor 1000 b can be then slid alongthe body 1052 of the inserter 1050 opposite the stop 1056, rotated about180 degrees to be positioned directly behind the stop 1056 and deployedoff the inserter 1050 similarly to the deployment of the first anchor1000 a. In one aspect, the anchors 1000 a and 1000 b can be mounted in akeyed manner onto the inserter 1050, such that accidental relativerotation can be substantially prevented without preventing intentionalsliding and rotation of the anchors. In a related aspect, more than twoanchors can be loaded on the inserter 1050. Two additional anchors, forexample, can be loaded behind the stop 1056. In this aspect, the fouranchors can be loaded at 90-degrees circumferentially apart on theinserter 1050, and can be deployed sequentially, with a 90-degreerelative rotation of the inserter 1050 relative to each anchor, afterdeployment of the previous anchor.

It will be appreciated from the above description and drawings that thepresent teachings provide anchors of versatile configurations that canbe passed through tissue easily in a compact or low profileconfiguration and or orientation and then positioned outside tissue in asecond orientation that provides anchoring without tissue penetration,preventing withdrawal from the tissue and reducing tissue injury.Further, the use of an inserter provided with preassembled anchors canhelp reduce the time length of the procedure and simplify manipulationsrequired during the procedure.

It will be further understood that the various embodiments of theinserters, anchors and coupling arrangements can be mixed and matched orcombined in ways other than those explicitly discussed above, withoutdeparting from the scope of the present teachings.

The foregoing discussion discloses and describes merely exemplaryarrangements of the present invention. One skilled in the art willreadily recognize from such discussion, and from the accompanyingdrawings and claims, that various changes, modifications and variationscan be made therein without departing from the spirit and scope of theinvention as defined in the following claims.

What is claimed is:
 1. A method for manufacturing a tissue repairassembly, the method comprising: positioning a first deformable tubeanchor and a second deformable tube anchor on a suture such that thefirst deformable tube anchor is received on the suture between a firstfree end of the suture and the second deformable tube anchor and thesecond deformable tube anchor is received on the suture between a secondfree end of the suture and the first deformable tube anchor, wherein thefirst deformable tube anchor being so received includes the sutureextending longitudinally through a first longitudinal bore in the firstdeformable tube anchor with the first free end of the suture extendingaway from a first end portion of the first deformable tube anchor, andwherein the second deformable tube anchor being so received includes thesuture extending longitudinally through a second longitudinal bore inthe second deformable tube anchor with the second free end of the sutureextending away from a first end portion of the second deformable tubeanchor; passing, after said receiving, the second free end of the suturethrough the first longitudinal bore in the first deformable tube anchorso that the suture extends a second time longitudinally through thefirst longitudinal bore in the first deformable tube anchor, whereinsaid passing: (i) positions the second free end of the suture outsidethe first deformable tube anchor extending away from a second endportion of the first deformable tube anchor; and (ii) leaves anadjustable loop portion of the suture outside the first deformable tubeanchor; and loading an inserter with the first deformable tube anchorand the second deformable tube anchor after said passing.
 2. The methodof claim 1, wherein said positioning leaves the first free end of thesuture protruding from a first aperture in a side wall of the firstdeformable tube anchor, the first aperture proximate the first endportion of the first deformable tube anchor.
 3. The method of claim 2,wherein said passing leaves the second free end of the suture protrudingfrom a second aperture in the side wall of the first deformable tubeanchor, the second aperture proximate the second end portion of thefirst deformable tube anchor.
 4. The method of claim 3, wherein thefirst longitudinal bore in the first deformable tube anchor extends fromthe first aperture in the side wall of the first deformable tube anchorto the second aperture in the side wall of the first deformable tubeanchor.
 5. The method of claim 1 further comprising placing a retainingdevice proximate the first free end of the suture.
 6. The method ofclaim 5, wherein the retaining device comprises a knot formed in thesuture.
 7. The method of claim 1, wherein the inserter includes a distalportion with an inclined sharp edge for piercing through meniscaltissue.
 8. A method for manufacturing a tissue repair assembly, themethod comprising: positioning a first deformable tube anchor and asecond deformable tube anchor on a suture, wherein the first deformabletube anchor is received on the suture between a first free end of thesuture and the second deformable tube anchor with the suture extending:(i) through a first aperture in a side wall of the first deformable tubeanchor; (ii) longitudinally within the first deformable tube anchoralong a first longitudinal bore in the first deformable tube anchor; and(iii) through a second aperture in the side wall of the first deformabletube anchor, wherein the second deformable tube anchor is received onthe suture between a second free end of the suture and the firstdeformable tube anchor with the suture extending: (i) through a thirdaperture in a side wall of the second deformable tube anchor; (ii)longitudinally within the second deformable tube anchor along a secondlongitudinal bore in the second deformable tube anchor; and (iii)through a fourth aperture in the side wall of the second deformable tubeanchor; and passing, after said receiving, the second free end of thesuture: (i) through the second aperture in the side wall of the firstdeformable tube anchor; (ii) longitudinally within the first deformabletube anchor along the first longitudinal bore in the first deformabletube anchor; and (iii) through the first aperture in the side wall ofthe first deformable tube anchor so that an adjustable loop portion ofthe suture with the second deformable tube anchor received thereon isleft outside the first deformable tube anchor.
 9. The method of claim 8,wherein the first longitudinal bore in the first deformable tube anchorextends from the first aperture in the side wall of the first deformabletube anchor to the second aperture in the side wall of the firstdeformable tube anchor.
 10. The method of claim 9 further comprisingplacing a retaining device proximate the first free end of the suture.11. The method of claim 10, wherein the retaining device comprises aknot formed in the suture.
 12. The method of claim 8 further comprisingloading an inserter with the first deformable tube anchor and the seconddeformable tube anchor, wherein the inserter includes a distal portionwith an inclined sharp edge for piercing through meniscal tissue.
 13. Amethod for manufacturing a tissue repair assembly, the methodcomprising: positioning a first deformable tube anchor and a seconddeformable tube anchor on a suture such that the suture extendslongitudinally through a first longitudinal bore in the first deformabletube anchor and longitudinally through a second longitudinal bore in thesecond deformable tube anchor with a second free end of the sutureextending away from a first end portion of the second deformable tubeanchor, wherein the first deformable tube anchor being so positionedincludes a second end portion of the first deformable tube anchorlocated along the suture between a first end portion of the firstdeformable tube anchor and the second deformable tube anchor, andwherein the second deformable tube anchor being so positioned includes asecond end portion of the second deformable tube anchor located alongthe suture between the first deformable tube anchor and the first endportion of the second deformable tube anchor, said positioningadditionally leaving the suture extending through an aperture in a sidewall of at least one of the first deformable tube anchor and the seconddeformable tube anchor; and passing, after said positioning, the secondfree end of the suture through the first longitudinal bore in the firstdeformable tube anchor so that the suture extends a second timelongitudinally through the first longitudinal bore in the firstdeformable tube anchor, wherein said passing: (i) positions the secondfree end of the suture outside the first deformable tube anchorextending away from the second end portion of the first deformable tubeanchor; and (ii) leaves an adjustable loop portion of the suture outsidethe first deformable tube anchor.
 14. The method of claim 13, whereinsaid positioning leaves a first free end of the suture outside the firstdeformable tube anchor.
 15. The method of claim 14, wherein saidaperture is a first aperture in a first side wall of the firstdeformable tube anchor, and wherein positioning leaves the first freeend of the suture protruding from the first aperture, the first apertureproximate the first end portion of the first deformable tube anchor. 16.The method of claim 15, wherein said passing leaves the second free endof the suture protruding from a second aperture in the first side wallof the first deformable tube anchor, the second aperture proximate thesecond end portion of the first deformable tube anchor.
 17. The methodof claim 16, wherein the first longitudinal bore in the first deformabletube anchor extends from the first aperture in the first side wall ofthe first deformable tube anchor to the second aperture in the firstside wall of the first deformable tube anchor.
 18. The method of claim13 further comprising placing a retaining device proximate the firstfree end of the suture.
 19. The method of claim 18, wherein theretaining device comprises a knot formed in the suture.
 20. The methodof claim 13 further comprising loading an inserter with the firstdeformable tube anchor and the second deformable tube anchor, whereinthe inserter includes a distal portion with an inclined sharp edge forpiercing through meniscal tissue.
 21. The method of claim 13 furthercomprising, threading the second free end of the suture longitudinallythrough a longitudinal passage in the suture to form a. firstself-locking adjustable loop.
 22. The method of claim 21, wherein saidpassing occurs after said threading and includes moving the longitudinalpassage in the suture at least partially into the first longitudinalbore in the first deformable tube anchor.
 23. A method for manufacturinga tissue repair assembly, the method comprising: passing a suturethrough at least part of a first longitudinal bore in a first deformabletube anchor and through at least part of a second longitudinal bore in asecond deformable tube anchor so that the first deformable tube anchorand the second deformable tube anchor, respectively, are received on thesuture between a first free end and a second free end of the suture;threading, after the first deformable tube anchor and the seconddeformable tube anchor are received on the suture, the second free endof the suture longitudinally through a longitudinal passage in thesuture to form a first self-locking adjustable loop; advancing, afterthe first deformable tube anchor and the second deformable tube anchorare received on the suture, the second free end of the suture into andthrough a portion of the first deformable tube anchor until the secondfree end is again positioned outside the first deformable tube anchorwith the first free end and the second free end extending from oppositeend portions of the first deformable tube anchor; and moving, after saidthreading, the longitudinal passage in the suture at least partiallyinto the first longitudinal bore in the first deformable tube anchor.24. The method of claim 23 further comprising positioning, after saidmoving, the first deformable tube anchor on an inserter.
 25. The methodof claim 23 further comprising forming a knot in the suture adjacent thefirst free end of the suture.
 26. The method of claim 25, wherein saidmoving leaves the knot outside the first longitudinal bore in the firstdeformable tube anchor.
 27. The method of claim 23, wherein saidthreading the second free end of the suture longitudinally through thelongitudinal passage in the suture to form the first self-lockingadjustable loop includes threading the second free end into the suturethrough a first aperture in the suture, longitudinally within the suturealong the longitudinal passage, and out of the suture through a fourthaperture in the suture to form the first self-locking adjustable loop,and wherein said moving places both the first aperture and the fourthaperture in the suture in the first longitudinal bore in the firstdeformable tube anchor.